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| Tracking Information | |||||
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| First Received Date ICMJE | January 11, 2008 | ||||
| Last Updated Date | July 30, 2009 | ||||
| Start Date ICMJE | April 2006 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00600106 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study | ||||
| Official Title ICMJE | WISE Ancillary Study Data Analyses:Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women With Normal/Minimal Coronary Artery Disease: Data Analysis | ||||
| Brief Summary | For the purposes of this study, as a core lab coordinating center, we will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. |
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| Detailed Description | Coronary endothelial cell dysfunction which results in vasoconstriction is a mechanism responsible for signs and symptoms of ischemia (decreased blood flow to the heart) in patients. Preliminary evidence in women suggests that estrogen levels may be involved. Women have more evidence of a decreased blood supply to the heart muscle even when they have normal coronary arteries compared to men. This is called Syndrome X. While animal and human work demonstrates that low estrogen levels make endothelial dysfunction worse, and that estrogen replacement eliminates this effect, this has not been evaluated in women suffering from Syndrome X. The impact of hormone replacement therapy on decreased blood flow to the heart muscle in female patients with normal coronary arteries (Syndrome X) is unknown. The primary purpose of the WISE Ancillary FemHRT study (IRB # 2779) was to evaluate the effect of estrogen replacement therapy with FemHRT in postmenopausal women with Syndrome X on: 1) inducible myocardial ischemia, measured by P-31 metabolic MR spectroscopy, and 2) endothelial dysfunction, measured by brachial artery reactivity measurement. Secondary outcomes of interest were to assess the effect of FemHRT on blood lipids hormone, glucose and insulin levels. For the purposes of this study, as a core lab coordinating center, we will be performing the following analyses on tapes, specimens, and data PREVIOUSLY collected as part of the original Ancillary WISE FemHRT Study (CSMC IRB#2779): P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. There is no active recruitment of subjects or samples, specimens or data that is currently and actively being collected. The analyses is retrospective on previously collected samples gathered from the WISE Anc. FemHrt study. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Retrospective | ||||
| Condition ICMJE | Coronary Disease | ||||
| Intervention ICMJE | Other: No intervention | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | January 2012 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00600106 | ||||
| Responsible Party | C. Noel Bairey Merz, MD/Medical Director, Cedars Sinai Medical Center | ||||
| Study ID Numbers ICMJE | 9260, 9260 | ||||
| Study Sponsor ICMJE | Cedars-Sinai Medical Center | ||||
| Collaborators ICMJE | Parke-Davis | ||||
| Investigators ICMJE |
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| Information Provided By | Cedars-Sinai Medical Center | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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